Class II · Moderate risk
Sterile EYE DROPS REDNESS LUBRICANT
Lack of Assurance of Sterility
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class II · Moderate risk
Sterile Eye Drops ORIGINAL FORMULA
Lack of Assurance of Sterility
Class II · Moderate risk
Ultra Lubricating Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Dry Eye Relief Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
EYE DROPS Advanced Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile EYE DROPS AC
Lack of Assurance of Sterility
Class I · High risk
Webcol Alcohol Prep pad
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Adbry
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
thiamine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
ketamine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
acyclovir sodium
Lack of Assurance of Sterility
Class II · Moderate risk
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
CHNaO Fluorescein Sodium Ophthalmic Strips
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Gonio Eye Lubricant
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced…
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Gel Hypromellose USP 0.3% w/v
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Tears Polyethylene Glycol 400 0.4% w/v
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
0.9% SODIUM CHLORIDE Injection
Lack of Assurance of Sterility: Potential for flexible container leaks.
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